Nick Daneman, Asgar Rishu, Ruxandra Pinto, Benajmin A Rogers, Yahya Shehabi, Rachael Parke, Deborah Cook, Yaseen Arabi, John Muscedere, Steven Reynolds, Richard Hall, Dhiraj B Dwivedi, Colin McArthur, Shay McGuinness, Dafna Yahav, Bryan Coburn, Anna Geagea, Pavani Das, Phillip Shin, Michael Detsky, Andrew Morris, Michael Fralick, Jeff E Powis, Christopher Kandel, Wendy Sligl, Sean M Bagshaw, Nishma Singhal, Emilie Belley-Cote, Richard Whitlock, Kosar Khwaja, Susan Morpeth, Alex Kazemi, Anthony Williams, Derek R MacFadden, Lauralyn McIntyre, Jennifer Tsang, Francois Lamontagne, Alex Carignan, John Marshall, Jan O Friedrich, Robert Cirone, Mark Downing, Christopher Graham, Joshua Davis, Erick Duan, John Neary, Gerald Evans, Basem Alraddadi, Sameera Al Johani, Claudio Martin, Sameer Elsayed, Ian Ball, Francois Lauzier, Alexis Turgeon, Henry T Stelfox, John Conly, Emily G McDonald, Todd C Lee, Richard Sullivan, Jennifer Grant, Ilya Kagan, Paul Young, Cassie Lawrence, Kevin O'Callaghan, Matthew Eustace, Keat Choong, Pierre Aslanian, Ulrike Buehner, Tom Havey, Alexandra Binnie, Josef Prazak, Brenda Reeve, Edward Litton, Sylvain Lother, Anand Kumar, Ryan Zarychanski, Tomer Hoffman, David Paterson, Peter Daley, Robert J Commons, Emmanuel Charbonney, Jean-Francois Naud, Sally Roberts, Ravindranath Tiruvoipati, Sachin Gupta, Gordon Wood, Omar Shum, Spiros Miyakis, Peter Dodek, Clement Kwok, Robert A Fowler
{"title":"Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections.","authors":"Nick Daneman, Asgar Rishu, Ruxandra Pinto, Benajmin A Rogers, Yahya Shehabi, Rachael Parke, Deborah Cook, Yaseen Arabi, John Muscedere, Steven Reynolds, Richard Hall, Dhiraj B Dwivedi, Colin McArthur, Shay McGuinness, Dafna Yahav, Bryan Coburn, Anna Geagea, Pavani Das, Phillip Shin, Michael Detsky, Andrew Morris, Michael Fralick, Jeff E Powis, Christopher Kandel, Wendy Sligl, Sean M Bagshaw, Nishma Singhal, Emilie Belley-Cote, Richard Whitlock, Kosar Khwaja, Susan Morpeth, Alex Kazemi, Anthony Williams, Derek R MacFadden, Lauralyn McIntyre, Jennifer Tsang, Francois Lamontagne, Alex Carignan, John Marshall, Jan O Friedrich, Robert Cirone, Mark Downing, Christopher Graham, Joshua Davis, Erick Duan, John Neary, Gerald Evans, Basem Alraddadi, Sameera Al Johani, Claudio Martin, Sameer Elsayed, Ian Ball, Francois Lauzier, Alexis Turgeon, Henry T Stelfox, John Conly, Emily G McDonald, Todd C Lee, Richard Sullivan, Jennifer Grant, Ilya Kagan, Paul Young, Cassie Lawrence, Kevin O'Callaghan, Matthew Eustace, Keat Choong, Pierre Aslanian, Ulrike Buehner, Tom Havey, Alexandra Binnie, Josef Prazak, Brenda Reeve, Edward Litton, Sylvain Lother, Anand Kumar, Ryan Zarychanski, Tomer Hoffman, David Paterson, Peter Daley, Robert J Commons, Emmanuel Charbonney, Jean-Francois Naud, Sally Roberts, Ravindranath Tiruvoipati, Sachin Gupta, Gordon Wood, Omar Shum, Spiros Miyakis, Peter Dodek, Clement Kwok, Robert A Fowler","doi":"10.1056/NEJMoa2404991","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bloodstream infections are associated with substantial morbidity and mortality. Early, appropriate antibiotic therapy is important, but the duration of treatment is uncertain.</p><p><strong>Methods: </strong>In a multicenter, noninferiority trial, we randomly assigned hospitalized patients (including patients in the intensive care unit [ICU]) who had bloodstream infection to receive antibiotic treatment for 7 days or 14 days. Antibiotic selection, dosing, and route were at the discretion of the treating team. We excluded patients with severe immunosuppression, foci requiring prolonged treatment, single cultures with possible contaminants, or cultures yielding <i>Staphylococcus aureus</i>. The primary outcome was death from any cause by 90 days after diagnosis of the bloodstream infection, with a noninferiority margin of 4 percentage points.</p><p><strong>Results: </strong>Across 74 hospitals in seven countries, 3608 patients underwent randomization and were included in the intention-to-treat analysis; 1814 patients were assigned to 7 days of antibiotic treatment, and 1794 to 14 days. At enrollment, 55.0% of patients were in the ICU and 45.0% were on hospital wards. Infections were acquired in the community (75.4%), hospital wards (13.4%) and ICUs (11.2%). Bacteremia most commonly originated from the urinary tract (42.2%), abdomen (18.8%), lung (13.0%), vascular catheters (6.3%), and skin or soft tissue (5.2%). By 90 days, 261 patients (14.5%) receiving antibiotics for 7 days had died and 286 patients (16.1%) receiving antibiotics for 14 days had died (difference, -1.6 percentage points [95.7% confidence interval {CI}, -4.0 to 0.8]), which showed the noninferiority of the shorter treatment duration. Patients were treated for longer than the assigned duration in 23.1% of the patients in the 7-day group and in 10.7% of the patients in the 14-day group. A per-protocol analysis also showed noninferiority (difference, -2.0 percentage points [95% CI, -4.5 to 0.6]). These findings were generally consistent across secondary clinical outcomes and across prespecified subgroups defined according to patient, pathogen, and syndrome characteristics.</p><p><strong>Conclusions: </strong>Among hospitalized patients with bloodstream infection, antibiotic treatment for 7 days was noninferior to treatment for 14 days. (Funded by the Canadian Institutes of Health Research and others; BALANCE ClinicalTrials.gov number, NCT03005145.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2404991","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Bloodstream infections are associated with substantial morbidity and mortality. Early, appropriate antibiotic therapy is important, but the duration of treatment is uncertain.
Methods: In a multicenter, noninferiority trial, we randomly assigned hospitalized patients (including patients in the intensive care unit [ICU]) who had bloodstream infection to receive antibiotic treatment for 7 days or 14 days. Antibiotic selection, dosing, and route were at the discretion of the treating team. We excluded patients with severe immunosuppression, foci requiring prolonged treatment, single cultures with possible contaminants, or cultures yielding Staphylococcus aureus. The primary outcome was death from any cause by 90 days after diagnosis of the bloodstream infection, with a noninferiority margin of 4 percentage points.
Results: Across 74 hospitals in seven countries, 3608 patients underwent randomization and were included in the intention-to-treat analysis; 1814 patients were assigned to 7 days of antibiotic treatment, and 1794 to 14 days. At enrollment, 55.0% of patients were in the ICU and 45.0% were on hospital wards. Infections were acquired in the community (75.4%), hospital wards (13.4%) and ICUs (11.2%). Bacteremia most commonly originated from the urinary tract (42.2%), abdomen (18.8%), lung (13.0%), vascular catheters (6.3%), and skin or soft tissue (5.2%). By 90 days, 261 patients (14.5%) receiving antibiotics for 7 days had died and 286 patients (16.1%) receiving antibiotics for 14 days had died (difference, -1.6 percentage points [95.7% confidence interval {CI}, -4.0 to 0.8]), which showed the noninferiority of the shorter treatment duration. Patients were treated for longer than the assigned duration in 23.1% of the patients in the 7-day group and in 10.7% of the patients in the 14-day group. A per-protocol analysis also showed noninferiority (difference, -2.0 percentage points [95% CI, -4.5 to 0.6]). These findings were generally consistent across secondary clinical outcomes and across prespecified subgroups defined according to patient, pathogen, and syndrome characteristics.
Conclusions: Among hospitalized patients with bloodstream infection, antibiotic treatment for 7 days was noninferior to treatment for 14 days. (Funded by the Canadian Institutes of Health Research and others; BALANCE ClinicalTrials.gov number, NCT03005145.).
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